Dear BTA Holders, This interview with Peter Cook CEO of BTA seems to have slipped under everyone's radar.
Some worthwhile /positive back ground on product development for example :
openbriefing.com Biotas partner Daiichi Sankyo filed a new drug application (NDA) in Japan for Laninamivir (CS-8958) in February after successful completion of Phase III clinical trials in Asia. Do you have any indication of the progress of the application and the likely start of royalty income flow?
CEO Peter Cook We filed in February and the official Japanese NDA guidelines require the authorities to have up to 12 months to consider the application. Weve been notified that the second committee of review has recommended approval for Laninamivir to the Department of Health, which is the second last stage in the approval process. So it would appear were tracking reasonably well to the 12 month timetable. Royalties will be paid on all sales of Laninamivir and wed expect those to start flowing in the first flu season after the drug gets approved.
openbriefing.com What progress have you made toward securing a licensee for Laninamivir outside Japan? Will Biota continue to independently progress the clinical trials necessary for approval in other markets while seeking a licensee?
CEO Peter Cook The last of the National Institutes of Health funded Western studies were completed during the 2010 financial year. We see that milestone, as well as the filing of the JNDA, as pretty good overall progress.
Rest of the world licensing activity is underway, although governments cancellation of vaccine orders post the swine flu pandemic and I've got to stress that Laninamivir is not a vaccine hasn't created a particularly good negotiating environment for us. The cancellation of those orders has made some of the big pharmaceutical companies wary of dealing with governments under these conditions again, and those sentiments will remain for the near term. Despite this temporary issue, both we and co-owner Daiichi-Sankyo see Laninamivir as a very valuable product for our shareholders.
In fact, Daiichi-Sankyo is making a very large investment in Laninamivir in taking it to market. We remain focused on crystallising the best value we can in the shortest possible time frame."
DYOR
Regards Kangaroo1
BTA Price at posting:
96.0¢ Sentiment: Hold Disclosure: Held
